Retro Access Vascular Sheath And Related Methods

Abstract

Disclosed herein are various vascular sheath embodiments for use in the introduction of interventional devices into a blood vessel of a patient. More specifically, disclosed herein are embodiments of a vascular sheath having at least one side access opening and at least one flexible area substantially adjacent to the side access opening.

Claims

1. A vascular sheath comprising: (a) an elongate body; (b) a lumen defined within the body; (c) a distal opening defined at a distal end of the body, wherein the distal opening is in fluidic communication with the lumen; (d) a proximal opening defined at a proximal end of the body, wherein the proximal opening is in fluidic communication with the lumen; (e) at least one side access opening defined in the body, wherein the at least one side access opening is positioned between the distal opening and the proximal opening; and (f) at least one flexible area disposed substantially adjacent to the side access opening.

2. The vascular sheath of claim 1, wherein the at least one flexible area is disposed along a length of the elongate body.

3. The vascular sheath of claim 1, wherein the at least one flexible area is disposed axially adjacent to the side access opening.

4. The vascular sheath of claim 1, wherein the at least one flexible area comprises: (a) a first flexible area axially adjacent to the at least one side access opening on a first side of the at least one side access opening; and (b) a second flexible area axially adjacent to the at least one side access opening on a second side of the at least one side access opening.

5. The vascular sheath of claim 1, wherein the at least one side access opening comprises: (a) a first side access opening defined in the body; and (b) a second side access opening defined in the body, wherein the second side access opening is radially adjacent to the first side access opening.

6. The vascular sheath of claim 1, wherein the at least one side access opening comprises: (a) a first side access opening defined in the body; and (b) a second side access opening defined in the body, wherein the second side access opening is disposed on a radially opposite side of the body in relation to the first side access opening.

7. The vascular sheath of claim 1, wherein the elongate body comprises: (a) a distal portion extending from the distal opening to the at least one side access opening; and (b) a proximal portion extending from the proximal opening to the at least one side access opening, wherein the at least one flexible area is configured to allow the proximal portion to be movable in relation to the distal portion at the at least one flexible area such that the proximal portion can be disposed at an angle in relation to the distal portion that is greater than 90 degrees.

8. A vascular sheath comprising: (a) an elongate body; (b) a lumen defined within the body; (c) a distal opening defined at a distal end of the body, wherein the distal opening is in fluidic communication with the lumen; (d) a proximal opening defined at a proximal end of the body, wherein the proximal opening is in fluidic communication with the lumen; (e) at least one flexible joint disposed on the elongate body between the distal opening and the proximal opening; and (f) at least one side access opening defined in the at least one flexible joint.

9. The vascular sheath of claim 8, wherein the at least one flexible joint is a concertina-type joint.

10. The vascular sheath of claim 8, wherein the at least one flexible joint comprises: (a) a first flexible area axially adjacent to the at least one side access opening on a first side of the at least one side access opening; and (b) a second flexible area axially adjacent to the at least one side access opening on a second side of the at least one side access opening.

11. The vascular sheath of claim 8, wherein the at least one side access opening comprises: (a) a first side access opening defined in the body; and (b) a second side access opening defined in the body, wherein the second side access opening is radially adjacent to the first side access opening.

12. The vascular sheath of claim 11, wherein the at least one flexible joint comprises: (a) a first flexible area axially adjacent to the first and second side access openings on a first axial side of the first and second side access openings; and (b) a second flexible area axially adjacent to the first and second side access openings on a second, opposite axial side of the first and second side access openings.

13. The vascular sheath of claim 8, wherein the at least one side access opening comprises: (a) a first side access opening defined in the body; and (b) a second side access opening defined in the body, wherein the second side access opening is disposed on a radially opposite side of the body in relation to the first side access opening.

14. The vascular sheath of claim 8, wherein the elongate body comprises: (a) a distal portion extending from the distal opening to the at least one flexible joint; and (b) a proximal portion extending from the proximal opening to the at least one flexible joint, wherein the at least one flexible joint is configured to allow the proximal portion to be movable in relation to the distal portion at the at least one flexible joint such that the proximal portion can be disposed at an angle in relation to the distal portion that is greater than 90 degrees.

15. A method of performing an interventional cardiac procedure, the method comprising: inserting a distal end of an elongate body of a vascular sheath through an incision and into a blood vessel; positioning the distal end of the vascular sheath in a first direction in relation to blood flow in the blood vessel; advancing a distal portion of an interventional device distally through a proximal opening in the vascular sheath, through a lumen defined within the vascular sheath, out of a distal opening in the vascular sheath and toward a first target area in the blood vessel; retracting the distal portion of the interventional device proximally through the distal opening and past an at least one side access opening defined in the elongate body; bending the elongate body at a flexible area disposed along the elongate body such that the proximal end of the vascular sheath is urged closer to the distal end; advancing the distal portion of the interventional device distally out of the at least one side access opening in a second direction in relation to the blood flow in the blood vessel toward a second target area in the blood vessel; and retracting the distal portion of the interventional device proximally through the at least one side access opening and through the proximal opening of the vascular sheath and out of the lumen.

16. The method of claim 15, further comprising retracting the distal end of the elongate body of the vascular sheath from the blood vessel after retracting the distal portion of the interventional device out of the lumen.

17. The method of claim 15, further comprising retracting the elongate body of the vascular sheath until the flexible area of the elongate body is disposed within the incision prior to bending the elongate body.

18. The method of claim 15, further comprising positioning the at least one side access opening adjacent to the incision prior to bending the elongate body.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 is a side view of a vascular sheath, according to one embodiment.

[0027] FIG. 2A is a cross-sectional side view of a vascular sheath being positioned in a blood vessel, according to one embodiment.

[0028] FIG. 2B is a cross-sectional side view of the vascular sheath of FIG. 2A being retracted and bent to allow access for the interventional device in the opposite direction in the blood vessel, according to one embodiment.

[0029] FIG. 3 is a cross-sectional side view of another vascular sheath positioned in a blood vessel, according to a further embodiment.

DETAILED DESCRIPTION

[0030] The various embodiments herein relate to a retro or dual-direction vascular sheath that can be inserted into a blood vessel in one direction and then adjusted to allow for access in the other direction without having to remove the sheath, and related methods.

[0031] One exemplary embodiment of a sheath 10 is provided in FIG. 1. The sheath 10 has a body 12 with a lumen 14 defined therethrough. The sheath 10 has a distal end 16 and a proximal end 18, wherein the proximal end includes a known three-way stop cock 28 and a side tube 30. Alternatively, the sheath 10 can have any known sheath components at or near the proximal end 18. The sheath 10 accommodates a dilator (not shown) that can be inserted into the lumen 14 through the stop cock 28 at the proximal end 18 and extends distally out of the distal end 16. In addition, the sheath 10 has first and second mid-length openings 20, 22 defined within the body 12 of the sheath 10, both of which also provide fluidic access to the lumen 14. In this embodiment, the two openings 20, 22 are disposed on opposite sides of the body 12 and radially adjacent as depicted. In accordance to one embodiment as shown, each of the openings 20, 22 has a curved or crescent shape as shown in the figure. Alternatively, the openings 20, 22 can have any other known shape for an opening in a sheath. Further, the sheath can have two flexible areas or joints 24, 26 along the length of the body 12. According to one embodiment, the flexible areas 24, 26 allow the sheath body 12 to bend at an angle exceeding 90 degrees. In this specific example, the flexible areas 24, 26 are positioned distally and proximally of the openings 20, 22 as shown. It is understood that these two flexible areas can also be described as a single flexible area 24, 26 with the two openings 20, 22 defined within the flexible area 24, 26. Alternatively, the flexible areas 24, 26 can be positioned anywhere along the length of the sheath body 12.

[0032] In one implementation, the flexible areas 24, 26 in the sheath body 12 are a series of grooves or ribs 24, 26 formed in the body 12, thereby creating flexibility in the body 12 where the grooves or ribs 24, 26 are located on the body 12. That is, in certain embodiments, the flexible areas 24, 26 form joints or hinges 24, 26 that are concertina-type joints or hinges 24, 26. Alternatively, the flexible areas 24, 26 can be created mechanically via any feature or component that is known to create flexibility in a sheath, catheter, or similar medical device. It is understood that any of the flexible areas in any implementations disclosed or contemplated herein can have features or structures similar or identical to those described above with respect to the flexible areas 24, 26.

[0033] According to one alternative, instead of two mid-length openings 20, 22 as shown in FIG. 1, the sheath can have only one opening on one side of the sheath body. For example, a sheath 80 having one mid-length opening 82 is shown in FIG. 3, according to one embodiment. In this embodiment, the sheath 80 also has one flexible area 84 on one side (without the opening) and two flexible areas 86A, 86B on the other side: a distal flexible area 86A and a proximal flexible area 86B. According to one implementation, the single mid-length opening 82 is formed in the side of the sheath 80 from which the side tube (not shown) extends, while in another implementation, the opening 82 is formed on the side opposite the side from which the side tube extends.

[0034] In use, the embodiments disclosed or contemplated herein can be used to insert a sheath into a blood vessel in one direction and then provide access to the other direction as necessary. For example, in one embodiment as depicted in FIG. 2A, a sheath 40 is inserted into a blood vessel 42 through an incision 44. In this implementation, the distal end 46 of the sheath 40 is inserted upstream (antegrade) in relation to the blood flow, which is depicted by arrow A, as shown. In this position, any interventional medical device can be introduced through the lumen 48 of the sheath 40 and out of the opening 50 at the distal end of the sheath 40 and advanced toward the target area.

[0035] However, if it is determined that an interventional device must be inserted downstream/in the retrograde direction (in the opposite direction of the distal end 46 of the sheath 40), a user (such as, for example, a surgeon) can take the following steps. First, as best shown in FIG. 2B, the user can urge the proximal end 52 of the sheath 40 forward (toward the distal end 46 of the sheath 40 in the direction depicted by arrow B) so that sheath 40 bends at the flexible areas 54, 56 such that the proximal end 52 is closer to the distal end 46 of the sheath 40. Once this bent configuration is achieved as depicted in FIG. 2B, the next step is that a device can be inserted through the sheath 40 such that the device extends out of the mid-length opening 58 in the direction opposite of the distal end 46, which, in this specific example, is downstream. That is, the bending of the sheath 40 and the insertion of the interventional device through the sheath 40 and out of the opening 58 allow for device access in the direction opposite the originally desired direction.

[0036] Once the procedure is completed, the interventional device can be retracted such that the device retracts through the mid-length opening 58, through the proximal portion of the sheath 40 and out of the sheath 40. At this point, the sheath 40 can be urged back into its original configuration as best shown in FIG. 2A and itself removed from the blood vessel 42 through the incision 44.

[0037] According another implementation, the alternative sheath 80 discussed above and depicted in FIG. 3 can be used in a similar fashion to the sheath 40. However, when using the alternative sheath 80, in one exemplary embodiment, the user positions the sheath 80 so that the mid-length opening 82 is accessible to the direction of the blood vessel 88 that is opposite the direction that the distal end 90 of the sheath 80 is disposed.

[0038] Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.